1. How can medical device software development improve to meet today’s cybersecurity challenges?
Cybersecurity threats are a daily concern for medical device companies, hospitals, doctors, and patients. It’s a matter of life or death – ensuring medical devices work properly and aren’t compromised by security threats and breaches. Also imperative is keeping patient data safe from hackers and criminals. As U.S. FDA guidelines stress, protecting medical device software and hardware from security risk is increasingly important in the development and operation of medical devices. One way to reduce cybersecurity risk is by foiling threats at the source. A medical device developer can get ahead of cybersecurity problems through vulnerability testing – known as penetration testing (pen testing) in the information technology (IT) world or fault injection in the embedded engineering community.
2. How does pen testing mitigate cybersecurity risk for medical device software development throughout a system’s lifecycle?
A pen test simulates an attack on a system or a medical device system to detect known vulnerabilities. A library of known attacks, or faults, drive an automated tool that injects each fault and analyzes the device-under-test (DUT) response. Testing uses the same binaries found in a production system but runs on a virtual device, so there’s no unintentional interference or damage by your test rig. As new vulnerabilities are discovered, you can add them to the library and improve your pen testing process. Pen testing is one of the best ways to mitigate cybersecurity risk, because it’s used throughout a system’s lifecycle: during development, deployment, and after each modification.
3. How can a medical device developer conduct pen testing on a software system being developed for their product?
One of the most effective ways to deploy pen testing is via cybersecurity simulation, a process used to expose known and unknown vulnerabilities by putting medical device security defenses under evolving, real-world security threat settings. Simulation engines, such as Wind River Simics, allow medical device system developers to test system cybersecurity in a controlled environment. Simics decouples your work from the physical hardware, while still retaining the ability to connect the physical medical device hardware when required. Simics virtual hardware gives on-demand access to any target system, supporting continuous integration and automated testing with members of your development team or suppliers.
4. How does Wind River Simics allow cybersecurity simulation for a medical device system?
Simics uses virtual hardware to conduct full system simulations, often the only way to detect cybersecurity threats originating with one component attacking others. Advantages of this approach are:
Conducting tests impossible on physical hardware, such as spoofing malware to trigger responses exposing its existence
Testing defense-in-depth strategies, such as flagging a suspect component as inoperable, isolating it from the system
Simics as a cybersecurity sandbox, safely containing suspect malware for forensic analysis
5. What other medical device system areas can use Simics’ simulation capabilities?
As medical devices and systems become more complex, Simics can help test by modeling complete networked systems, running a full production software stack – unmodified binaries, including binary input-output system (BIOS), firmware, operating systems, and applications. Recent Simics releases improve multicore and parallel core support. Fully parallel simulation is on the horizon, and Simics provides support for distributing complex, multi-core simulations across available host resources. The only restriction on system complexity or its performance requirements is the capacity of the simulation host network.
Employing an X-, Y-, and Z-axis; additional tilting A-axis (±120°) and a rotary C-axis (360°) with a 0.001° minimum indexing command, machining high-precision, complicated parts can be completed in one operation. Maximum workpiece of 220mm x 175mm (8.7” x 6.9”) and maximum table load capacity of 20kg (44 lb) provide flexibility and versatility when machining small, highly precise, intricate parts.
Standard high-speed, direct-drive 4th- and 5th-axis rotary tables offer smooth simultaneous 5-axis movement for complex cutting applications. With a rigid design and equipped with high resolution optical scale feedback on all axes, the MedCenter5AX offers positioning accuracy of ±0.002mm (±0.000079”) and full stroke for various small part machining.
The standard, high speed 30,000rpm, 18kW (24.5hp) direct-drive HSK-E40 spindle provides rigidity and spindle stiffness for fine finishing capabilities. Offering standard air through spindle for dry cutting, the machine is also equipped to handle up to 1,000psi coolant through the spindle for deep-hole drilling.
The 40 tool magazine enables 1.5 second tool changes with the tool magazine located toward the back of the machine for optimum operator access.
Pneumatic or electric grippers perform three basic functions:
Part transfer for machine tending, part placement, load/unload, boxing, palletizing Part orientation for applying a label, preparing tray inserton, box packaging Hold part in place to withstand applied work forces due to drilling, stamping, marking processes To better understand gripper capabilitites, and to select the proper style, consider these 8 questions.
1. What are the operating requirements?
Users and system integrators must take a big-picture view of the facility’s operations to decide whether an electric or pneumatic-driven gripper is best for operating.
• Electric grippers are quieter than pneumatics and minimize contaminates in sensitive environments. They provide analytical feedback about operating performance or part size and weight. Installation is easy as units connect directly to a control system/programmable logic controller (PLC) with basic standard wiring.
• Pneumatic grippers are faster, smaller, and cost less than an electric grippers, when comparing grip force to size ratios. Very noisy compared to electrics, they provide limited feedback to control systems, including grip part, or open/close status. Initial costs are low, but they have significant hidden costs. Grippers require air lines, filters, fittings, valves, and compressors to connect to a control system or PLC. Pneumatically powered grippers, or air-powered grippers, have been the standard with more than 95% in use.
High-precision grippers are ideal in several types of applications found in the medical and pharmaceutical industries.
2. Is the environment clean?
Operators must identify and implement the correct type of gripper that can withstand the operating conditions.
• Clean environments require keeping grease or contaminants on the gripper from being released into the work environment to avoid contaminating parts or processes. Ensuring clean manufacturing environments is common where very minute amounts of airborne or surface contaminants are allowed. Look for a gripper that is cleanroom-certified. Scavenge ports, available on many models, prevent contaminants from the gripper from escaping into the environment.
• Contaminated environments still must combat the effects of dirt, debris, oil, and grease. Purge ports can prevent contaminants from entering grippers while providing lubrication. The purge port, located on the gripper body, has a channel to the system’s internal mechanism. During gripper operation, a small amount of low-pressure air is introduced to keep positive pressure within the gripper housing, preventing contaminants from being drawn into the internal mechanism. In harsh operating environments, grease fittings can be used to purge dirty grease and/or add new grease to the unit.
3. Is a sealed gripper or shielded gripper required?
Standard or custom-designed shields can deflect debris away from gripper mechanisms or keep grease and internal containments from escaping into clean environments. Gripper shielding can be simple formed-sheet metal components or covers, flexible boots, bellows, or lip-style wipers. Users may add their own shielding during system integration. Orienting the gripper in relation to the direction of contaminants striking the unit can minimize debris.
Pneumatic grippers can be made from various materials and specialized processes. Stainless steel, nickel-plating, and hard-coat anodizing keep surfaces from corroding and can prevent debris from sticking, a condition that eventually causes gripper jaws to bind. In cleanroom applications, coatings can prevent oxidation or bacteria buildup.
Lubrications can be high-temperature or water-resistant to better handle specific environments or wash-down maintenance requirements. Pneumatic seals that handle extreme temperatures or grit and debris play a role in shielding. Buna-N (nitrile) is the industry standard, with Viton and silicone selected for higher temperatures. Metal seals allow grippers to handle extreme heat and/or contamination.
4. What are key specifications?
A gripper consists a body (including power transmission), jaws, and fingers. Generally, gripper manufacturers only design and build gripper bodies and jaws – known as the actuation mode. The machine builder or user typically supplies custom fingers to grip or encapsulate the given part. When selecting a gripper, consider appropriate finger length; excess can cause a gripper to bind. When considering grip force, too much will damage the part and too little will drop parts. Gripper stroke is also important as too much stroke wastes operation time, and too little will incorrectly grip or release parts. Grippers have various actuation times that will impact throughput rates. Repeatability is more important than accuracy and becomes a key specification if trying to pick up very small objects (syringe needles), or working in a high-precision application where one object is being placed inside another for assembly. 5What type of jaw-support mechanisms should be considered? Various grippers may be the same size and perform the same function but can have completely different designs.
High-impact loading application require a plain or wedge-type bearing design – a large sliding surface contact bearing, such as flat surface-to-surface bearings and cylindrical bushing-type bearings. A wide bearing surface area can withstand continuous high-impact loading and can maintain accuracy when machined to tight tolerances. Typically, there is zero-to-limited adjustability to compensate for gripper wear throughout time.
Low-friction high-accuracy applications benefit from line-contact roller-bearing designs such as cross-roller bearings and Dual V bearings. Bearing supporting jaws can be pre-loaded for high accuracy. This system is easy to maintain with external pre-load adjustability. Use in applications that require zero side play of the gripper fingers during the gripper’s lifetime. This low-friction design also allows an easy method of dialing in grip force by adjusting air pressure.
Low air pressure precision applications Can use a point-contact ball bearing design. This mechanism can operate at very low air pressures where smooth, consistent motion is critical. There is also reduced grease splatter from the gripper during operation The type of bearing used and the amount of surface contact employed in the bearing design will determine if the gripper can operate at very low air pressure, impact resistance, repeatability, wear patterns, and if gripper wear can be compensated for through bearing pre-load adjustability. 6What mode of power transmission is needed? Power transmission mode refers to the linkage and transfer of power from the internal air piston(s) to the gripper jaws that open and close.
High force-to-size applications require high grip force, but are constrained by the system’s working space. Double-sided wedge gripper designs with large surface areas for power transmission are often required. This style usually features a single-piston design that is capable of a high ratio of grip force-to-size. The gripper jaw/finger motion is synchronized without requiring additional components. The double-sided wedge can withstand high impact loads that may be imparted back onto the mechanism.
Parallel-gripper solutions use direct drive design with a pin or rod to couple the piston to the jaw. These are normally twin-piston designs and require a jaw-synchronizing linkage. The design is simple, cost effective, and easy to shield.
Angular-gripper solutions typically use a cam-driven design with direct, synchronized power transmission and bearing-line contact. This has one pivot point per jaw with a minimal number of moving parts. The cam can generate mechanical advantage, resulting in a gripper with high grip force in a relatively small overall package. The cam is commonly used in angular-jaw-motion grippers but can be found in other gripper types.
High-precision high-repeatability applications benefit from the smooth, synchronous operation of a rack-and-pinion drive systems that produce minimal wear for long durability. A rack and pinion, machined to tight tolerances, will produce zero to very little jaw play when installed and make it very easy to build a non-synchronous jaw gripper.
7. What are the best finger designs, gripping methods?
Gripper fingers design should prevent dropping a part under loss of air pressure whenever possible. A safety analysis can minimize risk of injury or system damage from a dropped part. Pay attention to the material used for gripper fingers and the gripping surface of the product. To avoid grip marks, use nylon, delrin, plastics, and other soft materials for gripper fingers instead of aluminum and steel. For fragile parts, urethane pads can be placed on the finger, which will increase gripping friction without imparting undue force that may cause damage.
There are several types of grippers to fit multiple applications.
Popular gripping methods include:
• Friction grip, the most common gripping method, has contact surfaces that close and stop on the part, creating a frictional force that holds the workpiece. If air pressure is lost, the part will drop unless the gripper has built-in safety mechanisms. Friction fingers should be avoided when handling oily or greasy parts.
Custom fingers can be designed for specific applications.
• Cradled grip allows the fingers to profile the part being handled, (round to round). The fingers close and apply force on the part like a cradle. If air pressure is lost, the part is typically held in place. If the weight of the part is significant enough to offset the backdrive force required to open the gripper, then fingers may cam open due to gravity, allowing the part to drop.
• Encapsulated, generally considered the most secure grip, allows fingers to have a profile of the part. Close and stop on or near the part, and the encapsulation can keep the part in position. If air pressure is interrupted, the part will not drop unless acted on by an external force.
8. What other safety features should be considered?
During a power failure that causes an operational air pressure loss, there are other means of preventing a part from accidentally releasing from the gripper and causing injury or part damage.
An internal spring can bias the piston and maintain finger/jaw position on or around the part. Care must be taken to ensure adequate spring force. A second option is using external fail/safe valves that are added to the ports to check air to the gripper in the open or closed position. A third option is the use of rod locks that automatically clamp on the guide rods of the jaws when air pressure is lost. Some, but not all, gripper styles can support rod locks.
Conclusion
Several pneumatic grippers perform the same function, but it is their unique features and capabilities that determine if they will operate long term in various applications.
The right size and right type of gripper can only be specified after all options are considered. Should there be any question to the suitability of a gripper to an application, contact the manufacturer to validate the gripper performance requirements to the allocated budget.
About the author: Gary Labadie is the global product director, Engineering for Destaco, Auburn Hills, Michigan. He can be reached at glabadie@destaco.com.
As practitioners of medtech M&A and facilitators of strategic partnerships, we live in a world of deal-making. As you can imagine, Q1 2020 was a wild ride.
In these days of instant media and the 24-hour news cycle, it’s difficult for medtech executives to evaluate real and fake news so quickly disseminated globally.
It used to be easier to discern information before making decisions on how to react to evolving scenarios. Today, situations can rapidly change, and the need to act decisively can happen quickly. During the recent explosion of the coronavirus (COVID-19), it was okay to travel to certain parts of the world one day, but not the next. We were in Korea in February when the incidence rate was low and woke up to news of rapid increases of new patients with COVID-19. Within three days, Korea was on the quarantine list. In and out just in time, whew.
The stock market has reacted to COVID-19 and concerns about which candidate may be elected in the U.S. presidential elections.
So how does one make good business decisions during these times? And, if you’re running a global business with a desire to grow, how do you make deals with travel restrictions in place?
Before initiating any new agreements, take a deep breath and resume your normal decision-making processes. However, you may need to make them quicker than normal. That’s okay. You will make some mistakes but it’s likely that your past decisions weren’t 100% satisfactory either.
Decisions on deals that have long-term strategic impacts should be an easy choice. Even if there may be some negative short-term results, if the deal fits the criteria you established last quarter and makes sense for 2021 (and beyond), you should move forward – even if the 2020 implications are not as exciting as they were in January.
Short-term deal choices with short-term impacts may take more thinking, and decisions should be made quickly. For example, you may have the opportunity to change suppliers if your vendor is underperforming now. It sounds easy at first, but you may need the supplier for future situations. On the other hand, if you can turn it into a dual-source scenario, it may have positive short-term and long-term impacts.
Regardless of your decision-making process, we’re guessing 2020 has contributed to you sharpening your saw on your ability to make important choices in a timely manner.
What’s next? We know the presidential elections will contribute volatility through November. Beyond that, your crystal ball is as good as ours. However, what we do know is that you’ll be more prepared for managing any scenario than when you started 2020!
About the authors: CEO Florence Joffroy-Black is a long-time medtech M&A and marketing expert. She can be reached at florencejblack@medworldadvisors.com. Managing Director Dave Sheppard is a former medical OEM Fortune 500 executive. He can be reached at davesheppard@medworldadvisors.com.
Hyperfine Research Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for its bedside magnetic resonance imaging (MRI) system, clearing the way for device shipments this summer. The Hyperfine system costs 20x less, consumes 35x less power, and weighs 10x less than today’s fixed conventional MRI systems.
The Hyperfine point-of-care device innovates on MRI design, architecture, and workflow, with more than 100 patents issued or currently pending. The portable system wheels directly to the patient’s bedside, plugs into a standard electrical wall outlet, and is controlled via a wireless tablet. It addresses limitations of current systems to make MRIs more accessible.
Cynosure’s Potenza radiofrequency (RF) microneedling device received FDA approval. The Potenza device’s four modes (monopolar or bipolar, delivered at either 1MHz or 2MHz) offer more customized microneedling treatments for patients, allowing practitioners to deliver shallow and deep treatments from a single system. The device’s monopolar RF mode delivers energy across a large area of tissue for deep heating and skin tightening through soft tissue coagulation. The bipolar RF mode offers more concentrated delivery of energy to treat superficial tissue. The device is equipped with Tiger Tip technology to allow practitioners to expand the treatment zone and address more tissue per treatment.
The Novalung ECMO system pumps and oxygenates a patient’s blood, reducing stress on damaged organs. Additionally, Novalung offers an alternative for invasive mechanical ventilation, which can cause additional lung injury from the required air pressure.
Posted by Elizabeth Engler Modic
